New Blood Testing Technology is Cheaper, Faster, More Accurate and Less Invasive

Imagine how convenient it would be to get a battery of blood tests for under $30, with no prescription and your results ready in hours, not days!

A story that begins with a 19-year-old dropping out of college doesn’t sound like one that will have a happy ending. But in the case of Elizabeth Holmes, the money her parents had set aside for her education went instead to create Theranos, a biotech company that has raised $100 million over the past ten years. One of her high profile investors (former Secretary of State George Shultz) says that Holmes could be the “next Steve Jobs or Bill Gates.”

Her breakthrough technology has the potential to completely upend the blood testing business, which has remained unchanged for decades. We all know the drill: you visit a LabCorp or Quest Diagnostics facility, present the order from your doctor, wait and then have a vial of blood drawn for each test. The results are sent to your doctor in three to seven days, so you must see your doctor a second time to find out the results and what they mean. The total bill may be near a thousand dollars for a full battery of tests.

What LabCorps and Quest rarely disclose is that, even after all that, some test results may be off by as much as thirty percent plus or minus—a sixty percent error range!

While most healthy adults have little problem parting with multiple vials of blood, the situation is different for infants, children, the elderly, and cancer patients. Infants have tiny veins that can be difficult to locate, older children squirm and generally detest the entire procedure, elderly people may have collapsed veins, and cancer patients endure such frequent blood draws that the repeated punctures can damage their veins and cause clotting and collapse.

Enter Elizabeth Holmes. You stop into your local Walgreens and visit the Theranos Wellness Center—with or without an order from a doctor. A technician warms your hand to increase blood flow and then pricks your finger to squeeze out a few drops. A test for fasting glucose will set you back $2.70; a complete blood count is $5.35. And you have your results later that day.

Plus, Theranos’s technology is automated, removing most human error from the process. It can thus achieve much lower error rates, with claimed margins of “allowable error” of less than ten percent.

It’s not hard to see why investors are practically lining up to give Holmes their money.

The first Theranos Wellness Center opened last month in a Palo Alto, California, Walgreens, but Holmes hopes to one day have a center within five miles of everyone in the US. Anyone, whether insured or not, will be able to keep tabs on their own health, at a fraction of the cost and inconvenience of traditional blood testing. “Patients are empowered by having better access to their own health information, and then by owning their own data,” says Holmes.

Yet the road ahead is not necessarily clear for Theranos. CEO Holmes plans to compete primarily on price, with at least a fifty percent discount on the current Medicare fees for blood testing—conservatively saving Medicare $61 billion and Medicaid $96 billion over 10 years. One industry observer believes that this strategy is flawed, as doctors are accustomed to ordering tests from the two industry leaders, LabCorp and Quest Diagnostics, and if health insurers and Medicare are both willing to pay their prices, there is little reason for either doctors or patients to care that Theranos is cheaper.

The problem, of course, is that Medicare and Medicaid have a virtual monopoly on many health services. Medicare sets fees according to a clinical price schedule (essentially a price-control system), with little transparency on how it sets up these schedules. The only thing we know is that they are heavily influenced by a committee of the American Medical Association, a group which in turn is heavily subsidized by payments provided by a government enforced medical coding monopoly.

Medicare more often than not refuses to accommodate new diagnostic technologies. Moreover, it forbids billing for more than one blood test per year not directly connected to an illness or suspected illness. We all know that such blood testing is one of the most important features of an emerging new medicine. But Medicare does not care; they just see it as additional expense, even though it can save billions in the long run.

It is therefore unlikely that Medicare will adjust its approach even with lower costs like those offered by Theranos: the federally administered system may suffocate this budding technology. The federal price control system has encouraged very little innovation in blood testing for many years, precisely because it makes no connection between services and costs.

Still, with all the advantages offered by the Theranos method, it’s hard to see how it can fail to capture some percentage of the blood test business. A person might read an article about the importance of vitamin D in the morning and, on the spur of the moment, pop in to a Walgreens that afternoon to get a vitamin D 25-OH test (cost: $20.35), thus providing a near-immediate answer to the question of their own vitamin D level. Anyone who has ever had to try to convince their doctor of why a certain test is needed will appreciate the approach pioneered by Holmes—and with prices for some tests lower than an office co-pay, it may not be only the uninsured who will be walking into Theranos wellness centers on their own initiative.

The only thing that would make the Theranos product even better would be a kit to gather your own blood drop at home and drop it at Walgreen’s or another site. But that would probably come too if the government gets out of the way. As it happens, the Life Extension Foundation (LEF) offers two home blood tests: one to check your omega-3, 6, and 9 levels, and one to test for food allergies. As always, they offer discounts for LEF members.

I would use this service if it were in my area. I have insurance but between the co-pay, deductible for the lab test it would be advantageous to just pay for it and not involve the insurance company which is a ripoff. Between my wife and I we each see a doctor about once or twice a year, usually for routine stuff, yet we pay $1700.00 per month. The further we can get from the insurance companies the better we would be.

Gloria Clements

This is a wonderful prospect. I sincerely hope that we see this expand and continue. This would help so many people in so many ways. People would be likely to use this to give them an idea of whether they need to see a physician to treat a previously unknown condition. It would be wonderful for those who need blood work on a routine basis because of certain medications they must take. As someone who must take an anticoagulant (Coumadin) and must monitor my clotting time, I am very aware of the value of a method like this. I am so “needle phobic” that since my primary care doctor does not have the equipment necessary to check clotting time by a “finger stick”, I have had to borrow money to purchase my own meter to test at home. That meter costs approximately $2,000. My test strips cost $60 for a vial of six. I simply cannot endure having blood drawn using the regular veno-puncture method. I have no medical insurance, so my primary care doctor cannot refer me to a cardiologist who might have the equipment to test clotting time using a finger stick.

Diana Corl

How much is food allergy blood test kit?

Lorraine Kress

To be able to get your blood tested for whatever reason ,without a Dr.”s request, sounds like an excellent idea. People could save time and money by cutting out some unnecessary dr. visits, and maybe correct their condition themselves.

ken niehoff

I wholesale Life Extension products and order all blood tests form them. Even though it is out of pocket, I save money and get more comprehensive testing. The vitamin D test isn’t much more expensive then what you quoted. We need to take our health care into our oun hands. Blood testing is expensive and optimally many tests need to be retaken to inform treatment efficacy. The simpler and less expensive the better. I’m waiting for the day when we are implanted with a sensor and all we have to do is usse a smartphone to see all blood parameters in real time.

That sounds completely awesome and exciting I truly do hope it goes thru this is something we can all benefit from. Good job.

Audrey Toll

it’s a pity, the government has controlled medicine for over 50 years. how many lives could have been saved by all the non-invented technologies because of government controls. what a brilliant idea this woman has. i do wish her success.

Yvonne Neal

This new blood test seems like a no brainer to me. I don’t understand what the deterrents would be unless there is a threat to another company who is making SO much money off their tests that they don’t want the consumer to have access to this new test….
Please do the right thing and protect consumer rights.

A very disappointing article. A fingerprick for sample gathering is not new technology. This article is full of half truths and outright misconceptions. All doctors do not use Labcorp or Quest. A reputable lab will have an accuracy rate closer to 2%, not what this author has made up. Lab test prices are based on reagent costs, instrument , lab overhead, and other legitimate costs. While this methodology is only fairly accurate, it’s main point is accessibility. There is no need to lie and exaggerate to sell its positive points.

Windsor

I disagree with Christine Hanson. No one was saying doctors use LabCorp or Quest exclusively- it just happens that these 2 labs are the most well-known in the US. Nor is the article suggesting finger prick blood testing is itself new. The “new” aspect of it is the range of tests offered via finger pricking; previous small sample tests have offered limited testing options. Further, the turn around time for Therano’s blood testing is appealing, as it empowers patients to find out results promptly. Prior to the electronic storage of patient lab results (and even to this day), obtaining one’s own results from one’s doctor has been unnecessarily time consuming. This prolongs uncertainty and can potentially delay diagnosis and recovery.

The prices of many tests, including those offered by LabCorp and Quest, are only “legitimate” insofar as they are unreasonable. Many cash customers purchasing labs directly from the blood drawing sites at LabCorp or Quest pay double or more for various tests compared to the prices listed by blood test wholesalers who refer to these sites. Then there was the fact that LabCorp and Quest both defrauded Medicare and Medicaid for millions of dollars in blood testing, lying about prices, double billing for single tests, etc. Medicare fraud drives up prices for Americans in systemic ways.

I agree that a test on a smaller blood sample seems more prone to inaccuracy, but current tests offered by major vendors can be quite inaccurate. Inaccurate or suspect results from Quest’s vitamin D test was shown to be 3 to 4 times higher than you suggest (in 2007-2008, 7% – 8% of results were questionable). Scientists also stated that recent vitamin D tests were inaccurate in at least 40% of the samples analyzed (http://www.sciencedaily.com/releases/2012/06/120625152310.htm) . It is clear that something needs to be done to ensure greater testing accuracy.

Don Somsky

If the government or anyone else stands in the way of these blood tests we should get a petition going. We can send it to the White House and anywhere else that will help and show how messed up this country has become.
Don Somsky

patricia schiewe

If we would use our technology for our benefit and allow new ways of doing things we could save so much of our health care expense. What would it do if everyone knew from their blood test which direction their health is heading to problems.and could solve their problem by some simple and easy llifestyle changes. This is what I have done for my health the last 40 years and I just turned 80 and am in excellent health and have not used standard medical services in the 40 years.

When I was 40 I was in terrible health. My heart was worn out and my gall bladder did not work and with the help of an excellent alternative doctor I completely recovered from all of the conditions and have vibrant health at 80. I was so lucky to have figured out that the FDA, the AMA, and the whole drug scene was not for me. It takes a bit of effort to take charge of your health but the information is freely available thru the internet.

Felisa

Who is your doctor and where is he located I’m looking for a good natural/holistic doctor in Dallas area

Sounds like a great product and an overall improvement to healthcare. First of all, it’s inexpensive. It’s accurate with less margin of error. While fingersticks are more than a little “pin prick,” they useconsiderably less blood and blood preparation and need for special collection tubes for each test is elliminated, or minimized. Lab costs are cheaper, too. There doesn’t seem to be any problems. In fact, there appears to be only advantages. This deserves further consideration.

S C Fox

This is good news, but I’ve been using Life Extension/LabCorp for many years. I like the convenience, cost and the results come to me, not my doctor. I keep track of my results and share them with my care providers whoever they may be. Your report claims that LabCorp results can be as much as 60% inaccurate. Would you please verify and confirm the statements made in this article. That inaccuracy concerns me and would like to know where that statistic came from that you used. Thank you.

Locally there’s another company that competes with LabCorp, CompuNet Direct. They are now offering simple blood tests at reasonable pricing without a doctor’s precription. This is a new approach for them and I believe it’s because of the competition that they’ve started this program. If Theranos enters the picture locally (and their pricing is even less than CompuNet Director or LabCorp) it would be a good thing for consumers.

I have concerns also about home kits because of sanitation conditions of samples taken at home and how that might alter results, but perhaps there are measures in place to account for these concerns. I have personally used home kits (saliva samples) and sent to the lab packed in dry ice. There are several ways to test (blood as well as saliva) that are more cost efficient and allows the consumer to dictate and monitor their health.

I am a Cancer Survivor. I rely on an annual AMAS specific Antibody test (not an antigen) for Cancer every year. Anti-Malignin Antibody is elevated in 93 to 100% of cases in which active non-terminal malignancy is the clinico-pathological diagnosis.(They are 96% accurate) I’ll bet on those odds any day!
I have my PCP fill out a lab requisition form and I have the blood draw done at my local hospital. They centrifuge the blood serum sample, freeze it and I package it for overnight delivery to Oncolab Inc. in Boston. My doctor receives the results within 72 hours.
As a Cancer patient and a professional video producer I documented my entire journey from diagnosis through treatments on tape and made a men’s health documentary called ‘I Am Not Stubborn’.(Trailer On UTube). I wanted to interview Dr. Bogoch at Oncolab for the story but he is not allowed to advertise in any manner according to the FDA!
I have also had a finger prick, blood sample taken for a Biological Terrain Microscopy Session at my own expense. It was very rewarding! So, I can see a great opportunity for development of this service to humanity. My your struggle be rewarding and successful!!

Considering that over half the US population is deficient in Vitamin D, the potential is enormous.
The Vitamin D researchers believe that the blood value of all Americans should be at or above 50 ng’s for maximum health. It is about half that today and the trend is less Vitamin D in the blood due to consumption of dead foods, little exposure to the sun and toxins in our food and drugs we take that deplete Vitamin D. Read my article on the “Chicken and the Egg” It is an eye opener.
Some egg producers don’t even list Vitamin D on their carton. Fifty years ago it was a key source. Not today.

Thomas Braun President N2E+ for Life. Health Education is key to rejecting dead food and toxins.

Mary Ann

This sounds like live blood cell analysis which isn’t new. I have been tested this way several times over the years.

hank hudson

If it’s effective, inexpensive and simple to do you can expect the Govt. to outlaw it immediately. If it doesn’t bring in big $$$ to the govt., phama , or the MD profession — it will not be allowed. They have a monopoly and aren’t about to share it. So do what is best for your personal health — don’t rely on the medical profession or the govt.

Dave

Its a scam.

Mary Ann

This sounds like live blood cell analysis which isn’t new. I have been tested this way several times over the years.

Mary Ann

This sounds like live blood cell analysis which isn’t new. I have been tested this way several times over the years.

Mary Ann

This sounds like live blood cell analysis which isn’t new. I have been tested this way several times over the years.

Mary Ann

This sounds like live blood cell analysis which isn’t new. I have been tested this way several times over the years.

hank hudson

If it’s effective and inexpensive you can be sure that the Govt. will disallow it. There is too much $$$ to be made by the pharma, md, and govt. to let anything good be available to the public. Do what you can now, don’t wait until the govt. will disallow it.

Thank you so much for this new technology of cheaper and convenient blood test. But what can a patient be benefited from this test if you don’t have the right to buy your medicine (high blood pressure pills or diabetes pill or whatever) without a prescription?

Medical Technologist

First of all I work as a medical technologist in a hospital laboratory. Our lab is accredited by Joint Commission who inspects our lab and holds us to certain standards. Our instruments must be maintained and validated, QC must be run and documented to show that our results are correct. We must do linearity studies every 6 months. They ensure that we are following protocol for our patients.
We also take the time to look at slides of samples that have been flagged by the instrument as being “abnormal”. It is during visual inspection of these slides that a trained technologist can find subtle abnormalities in cell lines that may be the first indication of a leukemia or a lymphoma. By our discovering these issues early in the process, treatment can begin early in the disease leading to better outcomes for the patient. I am not sure I would rely on a finger stick being done in a drug store to find these issues. We also do more than 500 complete cell counts in a day at a medium sized hospital. Can these facilities accommodate a large volume of patients. I see many flaws in this system.

MedTech2

Faster better cheaper -Revolutionary technology all great terms that gets all of us excited! Holmes has taunted the faster and the cheaper but has not elaborated much on the better.

If you go get a test at Wallgreens for 10.00 and take that result to your Dr. What is he or she going to do with it? Even if given “normal ” or “therapeutic” ranges she is not elaborating what is the test is measuring. There are many sources of error that start with specimen collection. Capillary or fingerstick samples are not the “optimum” sample type for some test. Maybe this technology is different … We won’t know she tell us. It’s great to know they have a go to market strategy in place.. It seems a bit like putting the cart before the horse.

She has quite a bright board of directors..Including a former Senator but only 2 from a medical profession… She may have separate scientific advisory board.. I didnt see that …I just find that odd. and have to wonder is new legislation that will be passed to the company’s benefit. I love that they request job candidates have a degree from a “top university”.. didn’t she drop out?

Not trying to be a naysayer There are some questions that have not been answered yet..

Elisabeth Holmes makes Bernie Madoff looks like a saint. He LYING BY OMISSION and implying as if she devised something know is PATHETIC. She on purpose, in her interviews refuses to elaborate on the details, and has done a Master CON JOB assembling a Board of WHO’s WHO in Business and Politics. And she is a Stanford Dropout.

Very simple, nanotheranstics, Live Cell Microscopy and other terms she on purpose fails to not use, keeps the IGNORANCE IS BLISS reader totally uniformed.

True that she I brilliant in building a $9 Billion Dollar Company, but to imply through omission that she has devised something unique as if it is some Unique Proprietary Technology, is Ludricous.

Shame on you Elisabeth, the epitome of Embellishing facts and giving yourself credit for Making Billions, by failing the disclose that you have nothing more than a Theranostic Live Blood Cell Imaging Technology, yes your pricing is brilliant, business model is brilliant, even hiding the TRUTH is brilliant. But you are a CON and you LIE by Omission.
The pictures of your lab with the testing devices and you must have used your C + + network to create some amazing software.

If you don’t get caught and exposed, you will go done in history as the MOST BRILLIANT Con Woman.

AMAZING $ 9 Billion Con Job. If Bernie Madoff had taken courses from you, he would still be respected, as you are as a Brillian Business Person.

Joseph

Like most articles on the net (and in print too!) nowadays, this article sounds more like a paid promotion for Theranos than an objective piece of reporting. The article echos and amplifies Theranos’ claims. It fails to pose the slightest challenge to these claims. This is not good
reporting, at least not in health care.

What strikes me as odd and questionable with Theranos is that its board of directors are all very big name politicians like Henry Kissinger, William Perry and former big shot senators and navy admirals and generals. For executive management, unlike most companies, only Elizabeth Holms, the founder and CEO, is listed. Where are the medical and clinical experts?

Given how disruptive this can be to the consumer medical testing business, and how lucrative to venture investors and wall street, it looks like Theranos has assembled a board of grand politicians and generals to win the politics of this business. How did a 20 year old Stanford dropout can assemble people like Henry Kissinger, William Perry, Sam Nun, etc…into her company’s board? I guess big name silicon valley venture firms have their ways.

Another key question is: Have their test methods, devices, and results been reviewed and checked in actual medical and clinical practice? Lab tests are meaningful and useful in the context of one’s health status and actionable when interpreted and acted upon by a physician.

Technology tends to increase access and reduce cost drastically. Politicians and their Wall Street sponsors tend to do the opposite. I hope that Theranos’ tech will prove medically viable and fulfills
its claims. A lot more needs to change in the ecosystem for that to happen.

Bruce Stewart

You ask some very good questions. Assuming that all is legitimate how long before the FDA or state medical boards shut this down? The FDA accused 23 and Me of practicing medicine without a license. They will surely drum up some charges against Theranos to help their friends.

I love that the author states ” The only thing that would make the Theranos product even better would be a kit to gather your own blood drop at home and drop it at Walgreen’s or another site.” Because, that technology and convenient at home sample collection kit already exists, at least for a full cholesterol panel that is sold at Walgreens directly to the consumer. It’s called the Check Up America Cholesterol Panel from Home Access Health Corporation, and it is endorsed by the American Diabetes Association. Everything needed for the consumer to collect, package and mail (via USPS) their fingerstick blood sample to Home Access’s CLIA/CAP accredited lab is included in the kit. Home Access Health also provides the only FDA-approved, direct-to-consumer fingerstick blood testing kit (with at-home collection and complete anonymity) for HIV-1 and Hep-C. These are confirmatory diagnostic tests, not screens.

Home Access Health has other at home sample collection kits and lab testing for fingerstick blood, urine and stool (Colorectal Cancer Screening) that provide accurate testing but are not direct-to-consumer.

JV

M. Driskell is correct and there are others. New Century Diagnostics and Coremedica Labs are both CLIA and CAP accredited and they offer kits for a number of tests. They don’t sell the kits directly but you can purchase online from other sites and mail into their labs and get results online. I did the A1C and TSH and compared to my Labcorp results and they were pretty consistent.

Dave

This is a scam, a black box scam…PCR is genetic testing that does not work with blood.

If this (invention) was real they would be published in JAMA and splashed all over the medical world.

But with Obamacare anything to lower costs to make the goverment look good.